Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K093795
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K093795
Device Name
Thermometer, Electronic, Clinical
Applicant
ACTHERM, INC.
6F, NO.18 JHANYE 2ND RD.,
HSINCHU SCIENCE PARK
HSINCHU 30078 TW
Other 510(k) Applications for this Company
Contact
RICHARD HSIEH
Other 510(k) Applications for this Contact
Regulation Number
880.2910
More FDA Info for this Regulation Number
Classification Product Code
FLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/2009
Decision Date
03/12/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact